Impact of Intrathecal Morphine on Sleep Apnea Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2019-03-31

Brief Summary

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Intrathecal morphine is commonly used as an analgesic adjunct for hip arthroplasty performed under spinal anaesthesia. Sleep apnea syndrome is a condition that affects up to 10% of the patients. Effect of intrathecal hydrophilic opioids on the frequency and duration of apneic episodes is unknown. The objective of this randomised controlled trial is to investigate the effect of intrathecal morphine and surgery on apneic episodes.

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Detailed Description

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Conditions

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Sleep Apnea Syndromes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Bupivacaine with normal saline

Group Type PLACEBO_COMPARATOR

Bupivacaine with normal saline

Intervention Type DRUG

Isobaric bupivacaine 15 mg + normal saline 0.5 cc

Bupivacaine with intrathecal morphine

Group Type ACTIVE_COMPARATOR

Bupivacaine with intrathecal morphine

Intervention Type DRUG

Isobaric bupivacaine 15 mg + intrathecal morphine 100 mcg

Interventions

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Bupivacaine with normal saline

Isobaric bupivacaine 15 mg + normal saline 0.5 cc

Intervention Type DRUG

Bupivacaine with intrathecal morphine

Isobaric bupivacaine 15 mg + intrathecal morphine 100 mcg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* physical status I - III
* patients scheduled to undergo hip arthroplasty

Exclusion Criteria

* planned surgical duration more than 3 hours
* contraindication to spinal anaesthesia
* severe respiratory disease
* patient known and treated for sleep apnea syndrome

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No